Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00538&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved December 30, 2014 V&A # 2746 IP determines the parallel importation of a medicinal product authorized MONUROL 3 g 2 sobres de granulado para solucion oral EFG from Spain with return authorization number 76799 Codigo Nac. 694800-2 with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this Determination: importer: GMM Farma S.r.l. CIS di Nola, 80035-8105/10 Batches 8 Island Nola;
Package: MONUROL «Adults 3 g granules for oral solution» 2 sachets AIC Code: 043635010 (10) 19MNB2 (based on 32) dosage form: granules for oral solution an envelope contains: active ingredient: fosfomycin 3.0 g (as fosfomycin trometamol 5.631 g) Ingredients: saccharin, sucrose, Orange flavor, aroma Mandarin;
Medical indications: acute bacterial Cystitis, bacterial cystitis, urethral syndrome acute relapsing-acute bacterial bladder, urethritis non-specific bacterial.
Significant bacteriuria asymptomatic (pregnancy).
Postoperative urinary infections.
Prophylaxis of urinary tract infections in surgery and Transurethral diagnostic maneuvers.
Secondary secondary authorised repackaging repackaging at officine Pharma Partners S.r.l. Via Locchi 112-50141 Florence; De Health S.r.l. Via Antonio Biasini, 26-26015 Soresina (CR); FIEGE Logistics Italy S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI); S.C.F. S.n.c di Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda;
Classification for the purposes of new listings ' box: MONUROL «Adults 3 g granules for oral solution» 2 sachets AIC Code: 043635010; New listings ' class: C (nn) the package described above is placed in "special section" of the classroom under art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn), pending the submission by the holder of the AIP a possible application for different classification.
Classification for the purposes of delivery set: MONUROL «Adults 3 g granules for oral solution» 2 sachets AIC Code: 043635010; RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.
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